Compositions for the treatment of sweating and methods for making same

ABSTRACT

The invention describes novel compositions and methods utilized for treating disorders and/or conditions associated with the epidermal and/or dermal level of the skin. Such disorders include hyperhidrosis, bromhidrosis, and chromhidrosis, One representative composition of the invention comprises; water, alcohol, aluminum sesquichlorohydrate, hydroxypropyl methyl cellulose, polysorbate 20, isopropyl myristate, eucalyptus oil, silicone oil, alkyl benzoate, glycerine, talc, a hydrophillic silica, a hydrophobic silica, phenoxyethanol and ethylhexyl glycerine.

PRIORITY

This application is a divisional of and claims priority under 35 USC 120from U.S. nonprovisional application Ser. No. 15/433,023 filed Feb. 27,2017, which is a continuation-in-part of U.S. nonprovisional applicationSer. No. 15/266,727 filed Sep. 15, 2016, which is a nonprovisionalconversion of and claims priority under 35 USC 119 from ProvisionalApplication 62/216,202 filed Sep. 16, 2016, all entitled “Compositionsfor the Treatment of Sweating and Methods for Making Same”, the entirecontents of which are hereby incorporated by reference.

INTRODUCTION

The physiological act of sweating serves as the body's natural coolant,protecting it from overheating. When subjected to temperature increases,stress, or exercise, the body excretes sweat, a fluid comprising mostlywater along with minerals, lactate and urea, to cool the body byevaporation of the water. Human sweat glands disorders are common andcan have a significant impact on the quality of life and onprofessional, social, and emotional burdens. It is of paramountimportance to diagnose and treat them properly to ensure optimal patientcare. Hyperhidrosis is a medical condition characterized by excessivesweating in the armpits, palms of the hands, soles of the feet, face,scalp, and/or torso. Hyperhidrosis involves sweating in excess of theamount required for normal body activity levels and exposure to varioustemperate climates. There are two basic types of hyperhidrosis-primaryand secondary. For primary hyperhidrosis, the cause is unknown andexcessive sweating is localized in the armpits, hands, face, and/orfeet. Primary hyperhidrosis begins during childhood or earlyadolescence, worsens during puberty, and usually lasts over a person'slifetime. In secondary hyperhidrosis, which is less common than primaryhyperhidrosis, excessive sweating is caused by various medicalconditions and usually occurs over the entire body. Medical conditionsthat can cause secondary hyperhidrosis include hyperthyroidism,menopause, obesity, psychiatric disorders, and diabetes. Secondaryhyperhidrosis may also be caused by use of medications. In people withexcessive sweating or hyperhidrosis, this function is overactive andthey experience extreme sweating, more than is usual or necessary. Thisdisorder can be uncomfortable, it can cause significant embarrassmentand it can be emotionally debilitating. Excess sweating can occur on thepalms of the hands, soles of the feet, underarms, face, head, or acombination of these sites or other sites on the body. Excessivesweating can lead to further dermatological disorders and social stigma.It is estimated that approximately two percent of the population suffersfrom hyperhidrosis.

Bromhidrosis and chromhidrosis are rare disorders but are still equallydisabling as hyperhidrosis. Bromhidrosis occurs secondary to excessivesecretion from either apocrine or eccrine glands that become malodorouson bacterial breakdown. The condition is further aggravated by poorhygiene or underlying disorders promoting bacterial overgrowth,including diabetes, intertrigo, erythrasma, and obesity. Chromhidrosisis a rare dermatologic disorder characterized by secretion of coloredsweat with a predilection for the axillary area and the face. Treatmentis challenging in that the condition usually recurs afterdiscontinuation of therapy and persists until the age-related regressionof the sweat glands.

BACKGROUND

Numerous therapeutic options have been introduced with variable success.Novel methods with microwave-based and ultrasound devices have beendeveloped and are being tested in comparison to the conventionalapproaches. All treatment options for hyperhidrosis require frequentmonitoring by a dermatologist for evaluation of the therapeuticprogress. Over the counter antiperspirants are typically for use only onthe underarms and can be irritating or otherwise less than optimal oreffective for normal sweating. They can be ineffective in treatinghyperhidrosis. Higher strength antiperspirants prescribed for thehyperhidrosis can also cause significant irritation. Surgicalsypathectomy can cause unwanted compensatory sweating in other regionsof the body. Botulinum toxin injections are very painful when used fortreating palmar hyperhidrosis. Conventional tap water iontophoreticdevices like the above are less than optimal. They are inconvenient touse, and immobilize the patient during treatment. They are also requirethe use of relatively high electric currents, around 18 milliamps, andwhich may, depending on the design, be directed through major portionsof the body remote from the treatment area, including passing throughthe heart. They are typically painful for the person undergoingtreatment due to the high current. This is a particular problem in thattreatment often requires several sessions per week over a period ofweeks or months.

Conventional treatments for hyperhidrosis include the use ofantiperspirants, aluminum chloride, botulinum toxin injections, surgicalprocedures such as extrathoracic sympathectomy and electricalstimulation via tap water iontophoresis. Iontophoretic devices for thetreatment of hyperhidrosis are described in example U.S. Patent Appln.Publication No. 2004/0167461 to Nitzan et al. and U.S. Pat. No.6,223,076 to Tapper. WO 2010/027792 discloses the treatment ofhyperhidrosis using galvanic particulates. US 2009/0232746 discloses abase formulation system for antiperspirants comprising anamidomethicone, dimethicone gum, and silica.

Topical agents applied to the skin in the affected area are a knownfirst course of treatment for hyperhidrosis. Topical applicationsinclude anticholinergic drugs, boric acid, tannic acid, resorcinol,potassium permanganate, formaldehyde, glutaraldehyde and methenamine.Antiperspirant actives currently used in the industry are Lewis acids.Typically, such antiperspirant actives are partially neutralizedchloride salts of metal ions such as aluminum and zirconium.

U.S. Pat. No. 6,433,003 discloses methods for treating hyperhidrosisinvolving the topical administration of glycopyrrolate compounds tohumans. U.S. Pat. Nos. 5,730,964 and 5,512,555 teach methods of treatingsweat related conditions with compounds that are 5-alpha-reductaseinhibitors, such as finasteride, epristeride and cholestan-3-one, aloneor in combination with other active agents to treat conditions such asapocrine gland sweating, hyperhidrosis, and hydradenitis suppurativa.U.S. Pat. No. 4,885,282 describes a method for the treatment of skinsuffering from hyperhidrosis, ichthyosis or wrinkling, comprisingapplying to the affected area of a compound selected from the groupconsisting of mono- and dicarboxylic acids having 4 to 18 carbon atoms,a mercapto derivative thereof, a salt thereof, and an ester thereof.

US Pat. Application No. 20050196414 describes a method of administeringa botulinum toxin to a subject comprising topically applying to the skinor epithelium of the subject the botulinum toxin for prevention orreduction of symptoms associated with subjective or clinicalhyperhidrosis. US Pat. App. No. 20040192754 teaches compounds that canameliorate symptoms of idiopathic hyperhidrosis and associatedconditions include 5-HT2C receptor antagonists (i.e., ketanserin,ritanserin, mianserin, mesulergine, cyproheptadine, fluoxetine,mirtazapine, olanzapine, and ziprasidone) as well as 5-HT2C receptormodulators (i.e., inverse agonists, partial agonists, and allostericmodulators).

SUMMARY

In one aspect, the present invention features a composition provides acombination of aluminum sesquichlorohydrate with both hydrophobic andhydrophilic silica(s) disposed and/or infused in a water and alcoholbased solution and a method of making the same. The composition treatshyperhidrosis (excessive sweating), and comprises topically applying thecomposition to skin in need of treatment for this condition.

More specifically, the composition is an anti-sweating compositioncomprising; water, alcohol, aluminum sesquichlorohydrate, hydroxypropylmethyl cellulose, polysorbate 20, isopropyl myristate, eucalyptus oil,silicone oil, alkyl benzoate, glycerine, talc, a hydrophillic silica anda hydrophobic silica, phenoxyethanol and ethylhexyl glycerine.

The components of the composition may allow for ethylhexyl glycerine tobe replaced with chlorphenesin and caprylyl glycol.

The composition of the present invention also may comprise an aluminumhydrate and/or an aluminum chlorohydrate other than or includingaluminum sesquichlorohydrate.

One embodiment allows for the composition described to include onlyhydrophobic silica. Another embodiment allows for the compositiondescribed to include only hydrophilic silica.

In another embodiment, the hydrophilic silica is Aerosil 300 ® and thehydrophobic silica is Aerosil R812®.

In a further embodiment, the silicone oil is polydimethyl siloxane(PDMS).

In a still further embodiment the alcohol is 2-propanol, the alkylbenzoate is C12-C15 alkyl benzoate, and the glycerine is vegetablederived glycerine.

Additionally the present composition may consist essentially of thefollowing weight percentages of each component; 37-39 percent water,11-12 percent 2-propanol, 14-15 percent aluminum sesquichlorohydrate,12-13 percent hydroxypropyl methylcellulose, 4-5 percent polysorbate 20,0.5-1.0 percent isopropyl myristate, 0.5-2.0 percent eucalyptus oil,0.5-1.5 percent poly dimethyl siloxane, 1.0-2.0 alkyl benzoate, 0.5-1.0percent glycerine, 1.0-3.0 percent talc, 5.0-7.0 percent hydrophilicsilica, 4.0-6.0 percent hydrophobic silica, and 0.5-1.0 percent of thecombination of phenoxyethanol and ethylhexyl glycerine.

For this composition the ethylhexyl glycerine may be replaced withchlorphenesin and caprylyl glycol at between 0.5 and 1.0 percent.

In addition, this composition also may contain citric acid and/or aceticacid or other “weaker” acids. These substances can be added for pHadjustment or can be utilized to increase shelf life or to otherwiseimprove the properties of the final composition.

The composition of the present invention provides for any selection ofthe group consisting of: a lotion, a cream, a spray, a moisturizer, abalm, a paste, and a saline solution.

The composition of the present invention may also be used to improve thecondition of the foot, including sweating of the feet and all conditionsassociated with the feet.

One method for making an anti-sweating composition is as follows;

-   (i) adding purified and/or deionized and/or distilled water to a    vessel with the necessary amounts and concentrations of NaOH and/or    HCl or other strong base or strong acid to raise or lower the pH of    the water to 8.5 (±0.1);-   (ii) adding hydroxypropyl cellulose powder to the vessel and stir a    resulting solution until the powder is fully hydrolyzed;-   (iii) lower pH of said solution to 7.0 (±0.1) using a 1N HCl    solution and begin rapid mixing;-   (iv) adding Polysorbate 20 as an emulsifier for stabilizing oils    during mixing-   (v) adding aluminum sesquichlorohydrate during mixing, thereby    lowering pH of the solution-   (vi) adding silicone oil during mixing and ensuring viscosity of the    solution does not exceed 200 centipoise;-   (vii) adding isopropyl myristate during mixing;-   (viii) adding alkyl benzoate during mixing;-   (ix) adding eucalyptus oil during mixing;-   (x) adding glycerine during mixing;-   (xi) adding talc during mixing;-   (xii) adding hydrophobic silica slowly during mixing to avoid funing    of fumed silica into the atmosphere;-   (xiii) raising the mixing speed once full amount of the hydrophobic    silica is added to the solution;-   (xix) adding a combination of phenoxyethanol and ethylhexyl    glycerine as a preservative;-   (xx) adding hydrophilic silica in the same manner as steps (xii) and    (xiii);-   and;-   completing the composition by mixing until the composition is a    homogeneous cream-like consistency.

A method of using the composition is also provided for a subject and theadministering of the disclosed composition to the skin of the subject.

DETAILED DESCRIPTION

It is believed that one skilled in the art can, based upon thedescription herein, utilize the present invention to its fullest extent.The following specific embodiments are merely illustrative, and notlimitative of the remainder of the disclosure in any way whatsoever.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the invention belongs. Also, all publications, patentapplications, patents, and other references mentioned herein areincorporated by reference. Unless otherwise indicated, a percentagerefers to a percentage by weight (i.e., % (W/W)).

Definition of Terms

As used herein, a composition that is “substantially free” of aningredient means the composition that has about 2% or less of thatingredient by weight based on the total weight of the composition.Preferably, a composition that is substantially free of an ingredienthas about 1% or less, more preferably about 0.5% or less, morepreferably about 0.1% or less, more preferably about 0.05 or less, morepreferably about 0.01% or less by weight based on the total weight ofcomposition of the ingredient. In certain more preferred embodiments, acomposition that is substantially free of an ingredient is free of theingredient, i.e. has none of that ingredient in the composition.

As used herein, “cosmetically-acceptable” means that the ingredientswhich the term describes are suitable for use in contact with tissues(e.g., the skin or hair) without undue toxicity, incompatibility,instability, irritation, allergic response, and the like.

As used herein, “safe and effective amount” means an amount of theingredient or of the composition sufficient to provide the desiredbenefit at a desired level, but low enough to avoid serious sideeffects. The safe and effective amount of the ingredient or compositionwill vary with the area being treated, the age and skin type of the enduser, the duration and nature of the treatment, the specific ingredientor composition employed, the particular cosmetically-acceptable topicalcarrier utilized, and like factors.

As used herein, the term “treatment” means the alleviation orelimination of symptoms, and/or cure, and/or prevention or inhibition ofa disease or condition, specifically sweating.

As used herein, “sweating” refers to the excretion of perspiration fromthe pores of the skin. Sweating includes, but not limited to, 1)non-pathological sweating, such as thermally-induced, exercise-induced,or stress-induced sweating; and 2) pathological or excessive sweatingsuch as hyperhidrosis, including primary and secondary hyperhidrosis, aswell as focal and generalized hyperhidrosis. The invention is useful inany area of the body where sweating occurs such as the hands, feet,face, head, torso, or underarms (axilla).

Substantially: As used herein, the term “substantially” refers to thequalitative condition of exhibiting total or near-total extent or degreeof a characteristic or property of interest. One of ordinary skill inthe biological arts will understand that biological and chemicalphenomena rarely, if ever, go to completion and/or proceed tocompleteness or achieve or avoid an absolute result. The term“substantially” is therefore used herein to capture the potential lackof completeness inherent in many biological and chemical phenomena.

Suffering from: An individual who is “suffering from” a disease,disorder, or condition (e.g., any disease, disorder, or condition,including, but not limited to, any disease, disorder, or conditiondescribed herein) has been diagnosed with or exhibits symptoms of thedisease, disorder, or condition. In some embodiments, exemplarydiseases, disorders, or conditions include, but are not limited to, acondition associated with sweat glands or sebaceous glands, such asacne; hyperhidrosis; unwanted sweating; bromhidrosis; body odor;chromhidrosis; hair loss; psoriasis; actinic keratosis; dermalinfection; eczematous dermatitis (e.g., atopic dermatitis, etc.); excesssebum-producing disorder; burns; Raynaud's phenomenon; lupuserthythematosus; hyperpigmentation disorder, hypopigmentation disorder;skin cancer; etc.

Susceptible to: An individual who is “susceptible to” a disease,disorder, or condition (e.g., any disease, disorder, or condition,including, but not limited to, any disease, disorder, or conditiondescribed herein) is at risk for developing the disease, disorder, orcondition. In some embodiments, an individual who is susceptible to adisease, disorder, or condition does not display any symptoms of thedisease, disorder, or condition. In some embodiments, an individual whois susceptible to a disease, disorder, or condition has not beendiagnosed with the disease, disorder, and/or condition. In someembodiments, an individual who is susceptible to a disease, disorder, orcondition is an individual who has been exposed to conditions associatedwith development of the disease, disorder, or condition (e.g., theindividual has been exposed to an infectious agent; the individual hasbeen exposed to an environmental hazard thought to cause the disease,disorder, and/or condition; etc.). In some embodiments, a risk ofdeveloping a disease, disorder, and/or condition is a population-basedrisk (e.g., an individual carries a gene and/or allele associated withthe disease, disorder, and/or condition).

Symptoms are reduced: According to the present invention, “symptoms arereduced” when one or more symptoms of a particular disease, disorder orcondition is reduced in magnitude (e.g., intensity, severity, etc.) orfrequency. For purposes of clarity, a delay in the onset of a particularsymptom is considered one form of reducing the frequency of thatsymptom. To give but a few examples, where the condition in question isacne, symptoms of that condition are reduced when the (e.g., diameter,volume, etc.) and/or severity (e.g., redness, inflammatory response,etc.) of one or more blemishes in the selected area is reduced, and/orwhen the number of total blemishes is reduced (e.g., on a subject'sface, back, etc.). Where the condition in question is hyperhidrosisand/or unwanted sweating, symptoms are reduced when the subject producesless sweat. It is not intended that the present invention be limitedonly to cases where the symptoms are eliminated. The present inventionspecifically contemplates treatment such that one or more symptomsis/are reduced (and the condition of the subject is thereby “improved”),albeit not completely eliminated.

Therapeutically effective amount: As used herein, the term“therapeutically effective amount” means an amount that is sufficient,when administered to a population suffering from or susceptible to adisease, disorder, and/or condition, to treat the disease, disorder,and/or condition. In some embodiments, a therapeutically effectiveamount is one that reduces the incidence and/or severity of, and/ordelays onset of, one or more symptoms of the disease, disorder, and/orcondition. Those of ordinary skill in the art will appreciate that theterm “therapeutically effective amount” does not in fact requiresuccessful treatment be achieved in a particular individual. Rather, atherapeutically effective amount may be that amount that provides aparticular desired pharmacological response in a significant number ofsubjects when administered to patients in need of such treatment. It isspecifically understood that particular subjects may, in fact, be“refractory” to a “therapeutically effective amount.” To give but oneexample, a refractory subject may have a low bioavailability such thatclinical efficacy is not obtainable. In some embodiments, reference to atherapeutically effective amount may be a reference to an amount asmeasured in one or more specific tissues. Those of ordinary skill in theart will appreciate that, in some embodiments, a therapeuticallyeffective agent may be formulated and/or administered in a single dose.In some embodiments, a therapeutically effective agent may be formulatedand/or administered in a plurality of doses, for example, as part of adosing regimen.

Therapeutic agent: As used herein, the phrase “therapeutic agent” refersto any agent that has a therapeutic effect and/or elicits a desiredbiological and/or pharmacological effect, when administered to asubject. Exemplary therapeutic agents include but are not limited tobotulinum toxins and monoclonal antibodies and fragments thereof.

Toxic solvent: As used herein, the term “toxic solvent” refers to anysubstance that may alter, disrupt, remove, or destroy an animal'stissue. As would be understood by one of ordinary skill in the art, ananimal's tissue can include living cells, dead cells, extracellularmatrix, cellular junctions, biological molecules, etc. To give but a fewexamples, toxic solvents include dimethyl sulfoxide, dimethyl acetimide,dimethyl formamide, chloroform, tetramethyl formamide, acetone,acetates, and alkanes.

Treatment: As used herein, the term “treatment” (also “treat” or“treating”) refers to any administration of a substance (e.g., providedcompositions) that partially or completely alleviates, ameliorates,relives, inhibits, delays onset of, reduces severity of, and/or reducesincidence of one or more symptoms or features of a particular disease,disorder, and/or condition. Such treatment may be of a subject who doesnot exhibit signs of the relevant disease, disorder and/or conditionand/or of a subject who exhibits only early signs of the disease,disorder, and/or condition. Alternatively or additionally, suchtreatment may be of a subject who exhibits one or more established signsof the relevant disease, disorder and/or condition. In some embodiments,treatment may be of a subject who has been diagnosed as suffering fromthe relevant disease, disorder, and/or condition. In some embodiments,treatment may be of a subject known to have one or more susceptibilityfactors that are statistically correlated with increased risk ofdevelopment of the relevant disease, disorder, and/or condition.

Unwanted side effects: As used herein, the term “unwanted side effects”refers to one or more effects and/or symptoms associated withadministration of a substance to a patient that are not the desiredand/or intended effects and/or are unpleasant to the patient. Exemplaryunwanted side effects include pain; bruising; ecchymosis; hematoma;botulism poisoning; unwanted systemic effects; undesirable blood levelsof the administered substance; damage to underlying nervous tissue(e.g., neuronal paralysis); unwanted effects on muscles (e.g., muscleparalysis); flu-like symptoms; morbidity; mortality; alteration in bodyweight; alteration in enzyme levels; pathological changes detected atthe microscopic, macroscopic, and/or physiological levels; infection;hemorrhage; inflammation; scarring; loss of function; changes in localblood flow; fever; malaise; teratogenesis; pulmonary hypertension;stroke; heart disease; heart attack; neuropathy; nausea; vomiting;dizziness; diarrhea; headache; dermatitis; dry mouth; addiction;miscarriage; abortion; uterine hemorrhage; birth defects; bleeding;cardiovascular disease; deafness; kidney damage and/or failure; liverdamage and/or failure; dementia; depression; diabetes; erectiledysfunction; glaucoma; hair loss; anaemia; insomnia; lactic acidosis;melasma; thrombosis; priapism; rhabdomyolysis; seizures; drowsiness;increase in appetite; decrease in appetite; increase in libido; decreasein libido; tardive dyskinesia; non-axillary sweating;

injection site pain and hemorrhage; pharyngitis; neck pain; back pain;pruritus; anxiety; follicular obstruction; and/or combinations thereof.In some embodiments, topical administration of a provided compositionsreduce unwanted side effects by about 50%, about 60%, about 70%, about80%, about 90%, about 95%, about 98%, about 99%, or about 100% relativeto non-topical administration (e.g., injection, oral administration,etc.) of the same substance.

Detailed Description of the Composition

In one embodiment, the composition comprises a combination of aluminumsesquichlorohydrate with both hydrophobic and hydrophilic silica(s)disposed and/or infused in a water and alcohol base. Further, thecomposition comprises at least one silicone oil. One additional exampleof a suitable silicone oil compositions in addition to the use ofdimethicone (PDMS-Polydimethylsiloxane), includes a blend comprising;cyclopentasiloxane, dimethicone, dimethicone crosspolymer, trisiloxane,silica, and dimethicone/vinyl dimethicone crosspolymer. Such a blend iscommercially available as DOW CORNING® CF-0055 Custom Blend.

The composition is preferably applied in a safe and effective amount forthe treatment of sweating. For example, the amount of a compositioncomprising a silicone applied to the palm of the hand is preferablyabout one-half the size of a pea. This amount may be applied severaltimes during the day, for example once in the morning, then throughoutthe day after each washing the hands or other removal of thecomposition, and then again at bedtime. Alternatively, the compositionmay be applied twice a day, in the morning and at bedtime, or appliedonce a day at bedtime.

In a primary embodiment, the use of aluminum sesquichlorohydrate is usedas the primary active ingredient that either eliminates, prevents, or atleast reduces excessive sweating or hyperhidrosis. A recentinvestigation by Innocenzi, et. al., entitled “An Open-LabelTolerability and Efficacy Study of an Aluminum SesquichlorohydrateTopical Foam in Axillary and Palmar Primary Hyperhidrosis”, published inDermatol Ther. 2008 July; 21 Suppl 1:S27-30. doi:10.1111/j.1529-8019.2008.00199 indicated that the aluminumsesquichlorohydrate foam indicated a significant reduction of eccrinesweating (61%) with only a single patient (out of 20) reporting any typeof skin irritation.

The composition may be applied to the treatment area in a variety offorms including but not limited to gels, creams, or sticks. In oneembodiment, the composition comprises a cosmetically-acceptable topicalcarrier.

As will be recognized by those of skill in the art,cosmetically-acceptable topical carriers comprise carriers that aresuitable for use in contact with the body, in particular the skin fortreatment of sweating, without undue toxicity, incompatibility,instability, irritation, allergic response, and the like. A safe andeffective amount of carrier is from about 50% to about 99.999%,preferably from about 80% to about 99.9%, more preferably from about99.9% to about 95%, most preferably from about 99.8% to about 98% of thecomposition. The carrier can take a wide variety of forms. For example,emulsion carriers, including, but not limited to, oil-in-water,water-in-oil, water-in-oil-in-water, and oil-in-water-in-siliconeemulsions, are useful herein. These emulsions can cover a broad range ofviscosities, e.g., from about 100 cps to about 200,000 cps. Examples ofsuitable cosmetically-acceptable topical carriers includecosmetically-acceptable solvents and materials for cosmetic solutions,suspensions, lotions, creams, serums, essences, gels, toners, sticks,sprays, ointments, liquid washes and soap bars, shampoos, hairconditioners, pastes, foams, mousses, powders, shaving creams, wipes,patches, strips, powered patches, microneedle patches, bandages,hydrogels, film-forming products, facial and skin masks, make-up, liquiddrops, and the like. These product types may contain several types ofcosmetically-acceptable topical carriers including, but not limited tosolutions, suspensions, emulsions such as microemulsions and gels,solids, liposomes, other encapsulation technologies and the like. Thefollowing are non-limitative examples of such carriers. Other carrierscan be formulated by those of ordinary skill in the art.

In one embodiment, the carrier contains water. In a further embodiment,the carrier may also contain one or more aqueous or organic solvents.Examples of organic solvents include, but are not limited to: dimethylisosorbide; isopropylmyristate; surfactants of cationic, anionic andnonionic nature; vegetable oils; mineral oils; waxes; gums; syntheticand natural gelling agents; alkanols; glycols; and polyols. Examples ofglycols include, but are not limited to, glycerin, propylene glycol,butylene glycol, pentalene glycol, hexylene glycol, polyethylene glycol,polypropylene glycol, diethylene glycol, triethylene glycol, caprylglycol, glycerol, butanediol and hexanetriol, and copolymers or mixturesthereof. Examples of alkanols include, but are not limited to, thosehaving from about 2 carbon atoms to about 12 carbon atoms (e.g., fromabout 2 carbon atoms to about 4 carbon atoms), such as isopropanol andethanol. Examples of polyols include, but are not limited to, thosehaving from about 2 carbon atoms to about 15 carbon atoms (e.g., fromabout 2 carbon atoms to about 10 carbon atoms) such as propylene glycol.The organic solvents may be present in the carrier in an amount, basedupon the total weight of the carrier, of from about 1 percent to about99.99 percent (e.g., from about 20 percent to about 50 percent). Watermay be present in the carrier (prior to use) in an amount, based uponthe total weight of the carrier, of from about 5 percent to about 95percent (e.g., from about 50 percent to about 90 percent). Solutions maycontain any suitable amounts of solvent, including from about 40 toabout 99.99%. Certain preferred solutions contain from about 50 to about99.9%, from about 60 to about 99%, from about 70 to about 99%, fromabout 80 to about 99%, or from about 90 to 99%.

A lotion can be made from such a solution. Lotions typically contain atleast one emollient in addition to a solvent. Lotions may comprise fromabout 1% to about 20% (e.g., from about 5% to about 10%) of anemollient(s) and from about 50% to about 90% (e.g., from about 60% toabout 80%) of water.

An alternative that may be used as a substitute for Euxyl PE9010 isMikrokill® COS, which is a unique, patented combination of threecomponents (Phenoxyethanol, Chlorphenesin and Caprylyl Glycol)manufactured by Lonza and which are also antibacterial compositions thatcan be interchangeably used with the composition presented in Table 1above.

Another type of product that may be formulated from the compositionalsolution provided in Table 1 is a cream. A cream typically contains fromabout 5% to about 50% (e.g., from about 10% to about 20%) of anemollient(s) and from about 45% to about 85% (e.g., from about 50% toabout 75%) of water.

Yet another type of product that may be formulated from thecompositional solution is an ointment. An ointment may contain a simplebase of animal, vegetable, or synthetic oils or semi-solid hydrocarbons.An ointment may contain from about 2% to about 10% of an emollient(s)plus from about 0.1% to about 2% of a thickening agent(s).

The compositions useful in the present invention can also be formulatedas emulsions. If the carrier is an emulsion, from about 1% to about 10%(e.g., from about 2% to about 5%) of the carrier contains anemulsifier(s). Emulsifiers may be nonionic, anionic or cationic.

Lotions and creams can be formulated as emulsions. Typically suchlotions contain from 0.5% to about 5% of an emulsifier(s), while suchcreams would typically contain from about 1% to about 20% (e.g., fromabout 5% to about 10%) of an emollient(s); from about 20% to about 80%(e.g., from 30% to about 70%) of water; and from about 1% to about 10%(e.g., from about 2% to about 5%) of an emulsifier(s).

Single emulsion skin care preparations, such as lotions and creams, ofthe oil-in-water type and water-in-oil type are well-known in the artand are useful in the subject invention. Multiphase emulsioncompositions, such as the water-in-oil-in-water type or theoil-in-water-in-oil type, are also useful in the subject invention. Ingeneral, such single or multiphase emulsions contain water, emollients,and emulsifiers as essential ingredients.

The compositions of this invention can also be formulated as a gel(e.g., an aqueous, alcohol, alcohol/water, or oil gel using a suitablegelling agent(s)). Suitable gelling agents for aqueous and/or alcoholicgels include, but are not limited to, natural gums, acrylic acid andacrylate polymers and copolymers, and cellulose derivatives (e.g.,hydroxymethyl cellulose and hydroxypropyl cellulose). Suitable gellingagents for oils (such as mineral oil) include, but are not limited to,hydrogenated butylene/ethylene/styrene copolymer and hydrogenatedethylene/propylene/styrene copolymer. Such gels typically containsbetween about 0.1% and 5%, by weight, of such gelling agents.

The compositions of the present invention can also be formulated into asolid formulation (e.g., a wax-based stick, soap bar composition,powder, or wipe). The composition of the present invention can also becombined with a solid, semi-solid or dissolvable substrate (e.g., awipe, mask, pad, glove or strip).

The composition is applied topically by simple rubbing with the fingers,spraying, or with other applicators known in the art of topicalcompositions, such as, but not limited to, a pad or wipe.

In one embodiment, the composition contacts substantially all, that is,at least 80 percent, preferably 90 percent, of the surface area of theskin in need of treatment. More preferably, the composition contactsall, that is, 100 percent, of the surface area of the skin in need oftreatment.

In an additional embodiment, the composition contains one or more otheringredients typically used in topical compositions, many of which arefamiliar to those skilled in the art. For example, the composition maycontain plant extracts, anti-inflammatory agents, antimicrobial agents,fragrances, or other active agents used to treat sweating.

Examples of plant extracts include, but are not limited to, feverfew,soy, glycine soja, oatmeal, what, aloe vera, cranberry, witch-hazel,alnus, arnica, artemisia capillaris, asiasarum root, birch, calendula,chamomile, cnidium, comfrey, fennel, galla rhois, hawthorn, houttuynia,hypericum, jujube, kiwi, licorice, magnolia, olive, peppermint,philodendron, salvia, sasa albo-marginata, natural isoflavonoids, soyisoflavones, and natural essential oils.

In another embodiment, the composition contains ingredients to alleviateor prevent skin irritation and inflammation. These ingredients mayinclude natural extracts, such as but not limited to feverfew, aloe, orchamomile. In another embodiment these ingredients may include topicalsteroids including corticosteroids, such as hydrocortisone. In yetanother embodiment, the composition may include nonsteroidalanti-inflammatory agents.

The composition of the present invention may also include a bufferingagent such as citrate buffer, phosphate buffer, lactate buffer,gluconate buffer, or gelling agents, thickeners, or polymers. The use ofa fragrance, for example one effective for reducing stress, calming,and/or affecting sleep such as lavender and chamomile may also beemployed.

The following non-limiting example in Table 1 further illustrates theinvention.

TABLE 1 Example 1: Composition for Treating Hyperhidrosis WeightConstituent (grams) Weight % Water 23.0 38.9 2-propanol (100%) 7.0 11.8Aluminum 8.8 14.9 Sesquichlorohydrate (active) Methocel ® 40-0101 3% 7.512.7 (Hydroxypropyl Methylcellulose) Polysorbate 20 2.0 3.4(Polyoxyethylene-chain length of 20 units and sorbitan monolaurate)Isopropyl Myristate 0.5 0.8 Eucalyptus Oil 0.5 0.8 Dimethicone (-PDMS-0.8 1.4 Polydimethylsiloxane) Alkyl Benzoate 1.0 1.7 Glycerin 0.5 0.8Talc 1.0 1.7 *Aerosil 300 (hydrophilic) 3.0 5.1 **Aerosil R812(hydrophobic) 3.0 5.1 ***Euxyl PE9010 0.5 0.8 TOTAL: 59.1 100.0*AEROSIL ® 300 is a hydrophilic fumed silica with a specific surfacearea of 300 m²/g, manufactured by Evonik Industries of Germany**AEROSIL ® R 812 S is a fumed silica “aftertreated” with HMDS(hexamethyl disiloxane) also manufactured by Evonik of Germany ***EuxylPE9010 (a liquid cosmetic composition containing phenoxyethanol andethylhexyl glycerine) and is manufactured by Schulke of Germany.

TABLE 2 Example 2: Composition for Treating Hyperhidrosis ConstituentWeight % Water 37.5 2-propanol (100%) 11.1 Aluminum 14.4Sesquichlorohydrate (active) Methocel ® 40-0101 3% 12.2 (HydroxypropylMethylcellulose) Polysorbate 20 4.9 (Polyoxyethylene-chain length of 20units and sorbitan monolaurate) Isopropyl Myristate 0.8 Eucalyptus Oil1.6 Dimethicone (-PDMS- 0.8 Polydimethylsiloxane) Alkyl Benzoate 1.6Glycerin 0.8 Talc 2.4 *Aerosil 300 (hydrophilic) 6.5 **Aerosil R812(hydrophobic) 4.1 ***Mikrokill ® COS 0.8 TOTAL: 100.0 *AEROSIL ® 300 isa hydrophilic fumed silica with a specific surface area of 300 m²/g,manufactured by Evonik Industries of Germany **AEROSIL ® R 812 S is afumed silica “aftertreated” with HMDS (hexamethyl disiloxane) alsomanufactured by Evonik of Germany ***Mikrokili ® COS which is a unique,patented combination of three components (Phenoxyethanol, Chlorphenesinand Caprylyl Glycol) manufactured by Lonza of Germany

In some embodiments, a cream and/or lotion formulation comprises and/orconsists essentially of the following proportions of ingredients:

TABLE 3 Example 3: Anti-Hyperhidrosis Cream and/or Lotion ConstituentWeight % Purified Water  40% Alcohol  12% Aluminum  15%Sesquichlorohydrate (active) White Petrolatum 2.0% Isopropyl Myristate4.0% Mineral Oil 1.9% Dimethicone (-PDMS- 1.4% Polydimethylsiloxane)Alkyl Benzoate 1.7% Glycerin 1.0% Emulsifying Wax 10.0%  *Aerosil 300(hydrophilic) 5.0% **Aerosil R812 (hydrophobic) 5.0% ***Euxyl PE90101.0% TOTAL: 100.0

In some embodiments, a saline solution for bulk formulation comprisesand/or consists essentially of the components found in Table 4 below;

TABLE 4 Example 4: Anti-Hyperhidrosis Saline Solution Constituent Weight% Isotonic Sodium Chloride  65% Solution Alcohol  10% Aluminum  15%Sesquichlorohydrate (active) Glycerin 1.0% Emulsifying Wax 3.0% ***EuxylPE9010 1.0% TOTAL: 100.0

The present invention encompasses the recognition that provided creamand/or lotion formulations can be particularly useful for topical and/ortransdermal administration. The present invention encompasses therecognition that provided cream and/or lotion formulations can beparticularly useful for delivery of agents to the dermal level of theskin. In some embodiments, provided cream and/or lotion formulations areformulated for topical and/or transdermal delivery to a subject in needthereof. In some embodiments, provided cream and/or lotion formulationsare administered to a subject in need thereof via topical and/ortransdermal delivery.

In further embodiments, provided cream and/or lotion formulationscomprise purified water, methylparaben, mineral oil, isopropylmyristate, white petrolatum, emulsifying wax, and propylparaben. In someembodiments, provided cream and/or lotion formulations comprise purifiedwater, mineral oil, isopropyl myristate, white petrolatum, andemulsifying wax. In some embodiments, provided cream and/or lotionformulations comprise the components set forth in Table 1.

In some embodiments, the present invention provides particular creamand/or lotion formulations as described herein. In some embodiments,provided cream and/or lotion formulations comprise water. In someembodiments, provided cream and/or lotion formulations comprisemethylparaben. In some embodiments, provided cream and/or lotionformulations comprise mineral oil. In some embodiments, provided creamand/or lotion formulations comprise isopropyl myristate. In someembodiments, provided cream and/or lotion formulations comprise whitepetrolatum. In some embodiments, provided cream and/or lotionformulations comprise emulsifying wax. In some embodiments, providedcream and/or lotion formulations comprise propylparaben. In someembodiments, provided cream and/or lotion formulations do not compriseany parabens. In some embodiments, provided cream and/or lotionformulations do not comprise methylparaben. In some embodiments,provided cream and/or lotion formulations do not comprise propylparaben.

The present invention encompasses the recognition that cream and/orlotion formulations can be particularly useful for formulatingcompositions, such as those described herein, for administration to asubject.

The present invention provides that surprising and/or unexpected resultscan be achieved when cream and/or lotion formulations are formulatedspecifically with aluminum sesquichlorohydrate as an active substance ina water and alcohol base.

In some embodiments, compositions comprise a mixture of one or morepharmaceutically acceptable excipients. In some embodiments, thesecompositions separately or together comprise a mixture of a salinesolution, and a cream and/or lotion formulation, as described herein.

In some embodiments, the present invention provides methods of treatingany mammalian skin conditions or disorders. In some embodiments, thepresent invention demonstrates that certain compositions as describedherein can achieve controlled delivery of active agents efficiently andspecifically to biologically relevant target sites (e.g., particulartissues, locations within the skin, cells, etc.). In some embodiments,the present invention demonstrates controlled delivery and/orachievement of a therapeutic effect in a certain biologically relevanttarget site without significant side effects associated with delivery toother areas.

In some embodiments, the present invention provides methods of treatingconditions or disorders associated with epidermal and/or dermalstructures (e.g., sweat glands, sebaceous glands, hair follicles, etc.).In some embodiments, the present invention demonstrates that providedcompositions as described herein can deliver active agents efficientlyand specifically to the dermis, and that provided compositions asdescribed herein can have therapeutic effects upon administration to theskin of a subject. In some embodiments, the present inventiondemonstrates dermal delivery and/or achievement of therapeutic effectwithout significant side effects associated with delivery to other areas(e.g., to subdermal or extradermal structures and/or to tissues otherthan dermis). In some embodiments, provided compositions may beformulated and/or delivered so that systemic delivery is achieved; insome embodiments, provided compositions may be formulated and/ordelivered so that local, but not systemic, delivery is achieved.

This application refers to various patent and non-patent publications,all of which are incorporated herein by reference.

Those of ordinary skill in the art will also be well aware of suitableoily media that can be used as dispersion media or as media to bedispersed in accordance with the present invention. In some embodiments,oils may comprise one or more fatty acid groups or salts thereof. Insome embodiments, a fatty acid group may comprise digestible,substituted or unsubstituted hydrocarbons. In some embodiments, a fattyacid group may be a C₆-C₅₀ fatty acid or salt thereof. In someembodiments, a fatty acid group may be a C₆-C₂₀ fatty acid or saltthereof. In some embodiments, a fatty acid group may be a C₆-C₁₆ fattyacid or salt thereof. In some embodiments, a fatty acid group may be aC₆-C₁₂ fatty acid or salt thereof. In some embodiments, a fatty acidgroup may be a C₆ fatty acid or salt thereof. In some embodiments, afatty acid group may be a C₈ fatty acid or salt thereof. In someembodiments, a fatty acid group may be a C₁₀ fatty acid or salt thereof.In some embodiments, a fatty acid group may be a C₁₂ fatty acid or saltthereof. In some embodiments, a fatty acid group may be unsaturated. Insome embodiments, a fatty acid group may be monounsaturated. In someembodiments, a fatty acid group may be polyunsaturated. In someembodiments, a double bond of an unsaturated fatty acid group may be inthe cis conformation. In some embodiments, a double bond of anunsaturated fatty acid may be in the trans conformation. In someembodiments, a fatty acid group may be one or more of butyric, caproic,caprylic, capric, lauric, myristic, palmitic, stearic, arachidic,behenic, lignoceric acid, and/or combinations thereof. In someembodiments, a fatty acid group may be one or more of palmitoleic,oleic, vaccenic, linoleic, alpha-linolenic, gamma-linoleic, arachidonic,gadoleic, arachidonic, eicosapentaenoic, docosahexaenoic, erucic acid,and/or combinations thereof.

In some embodiments, the comprises an oily dispersion medium thatcomprises, consists essentially of, or consists of a medium chaintriglyceride (e.g., fatty acids containing 6-12 carbons atoms, such ascaprylic acid, octanoic acid, capric acid, decanoic acid, lauric acid,etc., which, in some embodiments, may be obtained from coconut oil orpalm kernel oil). Exemplary medium chain triglycerides includemonounsaturated, and/or polyunsaturated soybean oil, coconut oil, canolaoil, safflower oil, olive oil, corn oil, cottonseed oil, linseed oil,safflower oil, palm oil, peanut oil, flaxseed oil, sunflower oil, ricebran oil, sesame oil, rapeseed oil, cocoa butter, almond oil, cashewoil, hazelnut oil, mongongo nut oil, acai oil, borage seed oil, eveningprimrose oil, carob pod oil, amaranth oil, apple seed oil, artichokeoil, avocado oil, babassu oil, ben oil, borneo tallow nut oil, cocoabutter, cocklebur oil, cohune oil, dika oil, grape seed oil, hemp oil,kapok seed oil, kenaf seed oil, lallemantia oil, marula oil, meadowfoamseed oil, mustard oil, papaya seed oil, perilla seed oil, pequi oil,poppyseed oil, prune kernel oil, quinoa oil, tea seed oil, thistle oil,tigernut oil, tomato seed oil, wheat germ oil, Labrafac™ Lipophile WL1349 oil, a silicone oil, a mineral oil, a lauroyl macrogol-6 glyceride,a lauroyl polyoxyl-6 glyceride, an oleoyl macrogol-6 glyceride, anoleoyl polyoxyl-6 glyceride, a linoleoyl macrogol-6 glyceride, alinoleoyl polyoxyl-6 glyceride, propylene glycol monocaprylate,propylene glycol monolaurate, propylene glycol monolaurate,polglyceryl-3 dioleate, propylene glycol dicaprylocaprate, diethyleneglycol monethyl ether, a caprylocaproyl macrogol-8 glyceride, acaprylocaproyl polyoxyl-8 glyceride, and/or combinations thereof.

In some embodiments, an oil is or comprises saturated, monounsaturated,and/or polyunsaturated short-chain fatty acids, medium-chain fattyacids, long-chain fatty acids, very-long-chain fatty acids, and/orcombinations thereof. In some embodiments, exemplary very-long-chainfatty acids include, but are not limited to, myristoleic acid,palmitoleic acid, sapienic acid, oleic acid, linoleic acid, alphalinolenic acid, arachidonic acid, eicosapentaenoic acid, erucic acid,docoshexaenoic acid, lauric acid, myristic acid, palmitic acid, stearicacid, arachidic acid, behenic acid, lignoceric acid, cerotic acid,and/or combinations thereof.

In some embodiments, an oil is selected from the group consisting ofshort-chain triglycerides, medium-chain triglycerides, long-chaintriglycerides, and/or combinations thereof. In some embodiments, ashort-chain triglyceride, a medium-chain triglyceride, and/or along-chain triglyceride selected from the group consisting of saturated,monounsaturated, and/or polyunsaturated soybean oil, coconut oil, canolaoil, safflower oil, olive oil, corn oil, cottonseed oil, linseed oil,safflower oil, palm oil, peanut oil, flaxseed oil, sunflower oil, ricebran oil, sesame oil, rapeseed oil, cocoa butter, almond oil, cashewoil, hazelnut oil, macadamia oil, mongongo nut oil, pecan oil, pine nutoil, pistachio oil, sachainchi oil, walnut oil, bottle gourd oil,buffalo gourd oil, butternut squash seed oil, pumpkin seed oil,watermelon seed oil, acai oil, blackcurrant seed oil, borage seed oil,evening primrose oil, carob pod oil, amaranth oil, apricot oil, apricotkernel oil, apple seed oil, argan oil, artichoke oil, avocado oil,babassu oil, ben oil, borneo tallow nut oil, cape chestnut oil, cassiaoil, cocoa butter, cocklebur oil, cohune oil, coriander seed oil, dikaoil, grape seed oil, hemp oil, kapok seed oil, kenaf seed oil,lallemantia oil, marula oil, meadowfoam seed oil, mustard oil, nutmegbutter, okra seed oil, papaya seed oil, perilla seed oil, pequi oil,poppyseed oil, prune kernel oil, quinoa oil, ramtil oil, royle oil, teaseed oil, thistle oil, tigernut oil, tomato seed oil, wheat germ oil,radish oil, salicornia oil, tung oil, algae oil, copaiba oil, honge oil,jatropha oil, petroleum nut oil, WL 1349 oil, a silicone oil, a mineraloil, a lauroyl macrogol-6 glyceride, a lauroyl polyoxyl-6 glyceride, anoleoyl macrogol-6 glyceride, an oleoyl polyoxyl-6 glyceride, a linoleoylmacrogol-6 glyceride, a linoleoyl polyoxyl-6 glyceride, propylene glycolmonocaprylate, propylene glycol monolaurate, propylene glycolmonolaurate, polglyceryl-3 dioleate, propylene glycol dicaprylocaprate,diethylene glycol monethyl ether, a caprylocaproyl macrogol-8 glyceride,a caprylocaproyl polyoxyl-8 glyceride, and/or combinations thereof.

In other some embodiments, an oil agent is or comprises saturated,monounsaturated, and/or polyunsaturated soybean oil, coconut oil, canolaoil, safflower oil, olive oil, corn oil, cottonseed oil, linseed oil,safflower oil, palm oil, peanut oil, flaxseed oil, sunflower oil, ricebran oil, sesame oil, rapeseed oil, cocoa butter, almond oil, cashewoil, hazelnut oil, macadamia oil, mongongo nut oil, pecan oil, pine nutoil, pistachio oil, sachainchi oil, walnut oil, bottle gourd oil,buffalo gourd oil, butternut squash seed oil, pumpkin seed oil,watermelon seed oil, acai oil, blackcurrant seed oil, borage seed oil,evening primrose oil, carob pod oil, amaranth oil, apricot oil, apricotkernel oil, apple seed oil, argan oil, artichoke oil, avocado oil,babassu oil, ben oil, borneo tallow nut oil, cape chestnut oil, cassiaoil, cocoa butter, cocklebur oil, cohune oil, coriander seed oil, dikaoil, grape seed oil, hemp oil, kapok seed oil, kenaf seed oil,lallemantia oil, manila oil, meadowfoam seed oil, mustard oil, nutmegbutter, okra seed oil, papaya seed oil, perilla seed oil, pequi oil,poppyseed oil, prune kernel oil, quinoa oil, ramtil oil, royle oil, teaseed oil, thistle oil, tigernut oil, tomato seed oil, wheat germ oil,radish oil, salicornia oil, tung oil, algae oil, copaiba oil, honge oil,jatropha oil, petroleum nut oil, WL 1349 oil, a silicone oil, a mineraloil, a lauroyl macrogol-6 glyceride, a lauroyl polyoxyl-6 glyceride, anoleoyl macrogol-6 glyceride, an oleoyl polyoxyl-6 glyceride, a linoleoylmacrogol-6 glyceride, a linoleoyl polyoxyl-6 glyceride, propylene glycolmonocaprylate, propylene glycol monolaurate, propylene glycolmonolaurate, polglyceryl-3 dioleate, propylene glycol dicaprylocaprate,diethylene glycol monethyl ether, a caprylocaproyl macrogol-8 glyceride,a caprylocaproyl polyoxyl-8 glyceride, bergamot, cade, camomile,caraway, carnauba, castor, cinnamon, cod liver, coffee, emu, eucalyptus,fish, geraniol, hyssop, jojoba, kukui nut, lavandin, lavender, lemon,litsea cubeba, mallow, mango seed, mink, orange, orange roughy, palmkernel, peach kernel, rosemary, sandalwood, sasquana, savoury, seabuckthorn, shea butter, tea tree, tsubaki, vetiver, butyl stearate,caprylic triglyceride, capric triglyceride, cyclomethicone, diethylsebacate, dimethicone 360, isopropyl myristate, octyldodecanol, oleylalcohol, and/or combinations thereof.

Suitable surfactants or emulsifying agents include, but are not limitedto, pemulen; phosphoglycerides; phosphatidylcholines; dipalmitoylphosphatidylcholine (DPPC); dioleylphosphatidyl ethanolamine (DOPE);dioleyloxypropyltriethylammonium (DOTMA); dioleoylphosphatidylcholine;cholesterol; cholesterol ester, diacylglycerol; diacylglycerolsuccinate;diphosphatidyl glycerol (DPPG); hexanedecanol; fatty alcohols such aspolyethylene glycol (PEG); polyoxyethylene-9-lauryl ether; a surfaceactive fatty acid, such as palmitic acid or oleic acid; fatty acids;fatty acid monoglycerides; fatty acid diglycerides; fatty acid amides:sorbitan trioleate (SPAN®85) glycocholate; sorbitan monolaurate(SPAN®20); polyoxyethylene monostearate; surfactin; a poloxomer: asorbitan fatty acid ester such as sorbitan trioleate; lecithin;lysolecithin; phosphatidylserine; phosphatidylinositol; sphingomyelin;phosphatidylethanolamine (cephalin): cardiolipin; phosphatidic acid;cerebrosides; dicetylphosphate; dipalmitoylphosphatidylglycerol;stearylamine; dodecylamine; hexadecyl-amine; acetyl palmitate; glycerolricinoleate; hexadecyl stearate; isopropyl myristate; tyloxapol;poly(ethylene glycol)5000-phosphatidylethanolamine: poly(ethyleneglycol)400-monostearate; phospholipids; synthetic and/or naturaldetergents having high surfactant properties; deoxycholates;cyclodextrins; chaotropic salts; ion pairing agents; sodium dodecylsulfate; pemulen; an amphiphilic entity having a head group based on apolyoxyethylene glycol sorbitan alkyl ester (e.g., as in a polysorbate(TWEEN®), a super-refined polysorbate (TWEEN®, and/or combinationthereof; including, but not limited to, polysorbate 20 (TWEEN®20);polysorbate 60 (TWEEN®60); polysorbate 65 (TWEEN®65); polysorbate 80(TWEEN®80); polysorbate 85 (TWEEN®85); super-refined polysorbate 20 (SRTWEEN®20): super-refined polysorbate 60 (SR TWEEN®60); super-refinedpolysorbate 65 (SR TWEEN®65) super-refined polysorbate 80 (SR TWEEN®80);super-refined polysorbate 85 (SR TWEEN®85); and/or combinationsthereof); an amphiphilic entity having a sulfate-based head group (e.g.,as in ammonium lauryl sulfate, sodium lauryl sulfate, sodium laurethsulfate, sodium myreth sulfate, etc.); an amphiphilic entity having asulfonate-based head group (e.g., as in dioctyl sodium sulfosuccinate,perfluorooctanesulfonate [PFOS], perfluorobutanesulfonate, alkyl benzenesulfonates, CHAPS(3-[(3-Cholamidopropyl)dimethylammonio]-1-propanesulfonate,cocamidopropyl hydroxysultaine, etc.); an amphiphilic entity having aphosphate-based head group (e.g., as in alkyl aryl ether phosphate,alkyl ether phosphate, lecithin, etc.); an amphiphilic entity having acarboxylate-based head group (e.g., as in fatty acids, sodium stearate,sodium lauroyl sarcosinate, carboxylate fluorosurfactants,perfluorononanoate, perfluorooctanoate [PFOA or PFO], amino acids, iminoacids, cocamidopropyl betaine, etc.); an amphiphilic entity having anamine-based head group (e.g., a primary, secondary, or tertiary amine,as in octenideine dihydrochloride); an amphiphilic entity having a headgroup comprising a quaternary ammonium ion (e.g., as in cetyltrimethylammonium bromide [CTAB] a.k.a. hexadecyl trimethyl ammoniumbromide, cetyl trimethylammonium chloride [CTAC], cetylpyridiniumchloride [CPC], polyethoxylated tallow amine [POEA], benzalkoniumchloride [BAC], Benzethonium chloride [BZT],5-Bromo-5-nitro-1,3-dioxane, Dimethyldioctadecylammonium chloride,Dioctadecyldimethylammonium bromide [DODAB]); an amphiphilic entityhaving a head group based on a fatty alcohol (e.g., as in cetyl alcohol,stearyl alcohol, cetostearyl alcohol, oleyl alcohol, etc.); anamphiphilic entity having a head group based on a polyoxyethylene glycolalkyl ether (e.g., as in octaethylene glycol monododecyl ether,pentacthylene glycol monododecyl ether); an amphiphilic entity having ahead group based on polyoxypropylene glycol alkyl ether; an amphiphilicentity having a head group based on a glucoside alkyl ether (e.g., as indecyl glucoside, lauryl glucoside, octyl glucoside, etc.); anamphiphilic entity having a head group based on a polyoxyethylene glycoloctylphenol ether (e.g., as in Triton X-100); an amphiphilic entityhaving a head group based on a polyoxyethylene glycol alkylphenol ether(e.g., as in nonosynol-9); an amphiphilic entity having a head groupbased on a glycerol alkyl ester (e.g., as in glyceryl laurate); anamphiphilic entity having a head group based on a sorbitan alkyl ester(e.g., spans); an amphiphilic entity that is or comprises cocamide MEA,cocamide DEA<dodecyl dimethylamine oxide; a block copolymer ofpolyethylene glycol and polypropylene glycol (i.e., a poloxamer); anamphiphilic entity having a tail group based on or containing ahydrocarbon chain: an amphiphilic entity having a tail group based on orcontaining an alkyl ether chain; an amphiphilic entity having a tailgroup based on or containing a polyethylene; an amphiphilic entityhaving a tail group based on or containing polypropylene oxide; anamphiphilic entity having a tail group based on or containing afluorocarbon chain; an amphiphilic entity having a tail group based onor containing a siloxane chain; and/or combinations thereof.

In some embodiments, a surfactant is a mixture of different surfactants.Surfactants may be extracted and purified from a natural source or maybe prepared synthetically in a laboratory. In some embodiments,surfactants are commercially available.

Gels may also be employed and one of ordinary skill in the art wouldreadily appreciate that gelatin itself may not be the only agent withdesirable attributes, such as those described herein, and could readilytest a variety of agents, particularly peptide agents, to identifyadditional agents having similar attributes and/or functions. Exemplarypeptide agents that could be tested for attributes and/or functionssimilar to those exhibited by gelatin include, but are not limited to,proteins derived from blood and/or plasma, including, but not limitedto, albumin, fibrin, thrombin, prothrombin, and/or combinations thereof.

In some embodiments, the present invention provides compositionscomprising one or more of a medium chain triglyceride, a polysorbate,and gelatin.

In some embodiments, oil and surfactant are utilized at a ratio rangingbetween 0.1 and 2. In some embodiments, the ratio of oil to surfactantis approximately 0.1:1. In some embodiments, the ratio of oil tosurfactant is approximately 0.15:1. In some embodiments, the ratio ofoil to surfactant is approximately 0.2:1. In some embodiments, the ratioof oil to surfactant is approximately 0.25:1. In some embodiments, theratio of oil to surfactant is approximately 0.3:1.

In some embodiments, the ratio of oil to surfactant is approximately0.35:1. In some embodiments, the ratio of oil to surfactant isapproximately 0.4:1. In some embodiments, the ratio of oil to surfactantis approximately 0.45:1. In some embodiments, the ratio of oil tosurfactant is approximately 0.5:1. In some embodiments, the ratio of oilto surfactant is approximately 0.55:1. In some embodiments, the ratio ofoil to surfactant is approximately 0.6:1.

In some embodiments, the ratio of oil to surfactant is approximately0.65:1. In some embodiments, the ratio of oil to surfactant isapproximately 0.7:1. In some embodiments, the ratio of oil to surfactantis approximately 0.75:1. In some embodiments, the ratio of oil tosurfactant is approximately 0.8:1. In some embodiments, the ratio of oilto surfactant is approximately 0.85:1. In some embodiments, the ratio ofoil to surfactant is approximately 0.9:1. In some embodiments, the ratioof oil to surfactant is approximately 0.95:1. In some embodiments, theratio of oil to surfactant is approximately 1:1. In some embodiments,the ratio of oil to surfactant is approximately 1:1.05. In someembodiments, the ratio of oil to surfactant is approximately 1:1.1. Insome embodiments, the ratio of oil to surfactant is approximately1:1.15. In some embodiments, the ratio of oil to surfactant isapproximately 1:1.2. In some embodiments, the ratio of oil to surfactantis approximately 1:1.25. In some embodiments, the ratio of oil tosurfactant is approximately 1:1.3. In some embodiments, the ratio of oilto surfactant is approximately 1:1.35. In some embodiments, the ratio ofoil to surfactant is approximately 1:1.4. In some embodiments, the ratioof oil to surfactant is approximately 1:1.45. In some embodiments, theratio of oil to surfactant is approximately 1:1.5. In some embodiments,the ratio of oil to surfactant is approximately 1:1.55. In someembodiments, the ratio of oil to surfactant is approximately 1:1.6. Insome embodiments, the ratio of oil to surfactant is approximately1:1.65. In some embodiments, the ratio of oil to surfactant isapproximately 1:1.7. In some embodiments, the ratio of oil to surfactantis approximately 1:1.75. In some embodiments, the ratio of oil tosurfactant is approximately 1:1.8. In some embodiments, the ratio of oilto surfactant is approximately 1:1.85. In some embodiments, the ratio ofoil to surfactant is approximately 1:1.9. In some embodiments, the ratioof oil to surfactant is approximately 1:1.95. In some embodiments, theratio of oil to surfactant is approximately 1:2. In some embodiments,the ratio of oil to surfactant is approximately 1:2.5. In someembodiments, the ratio of oil to surfactant is approximately 1:3. Insome embodiments, the ratio of oil to surfactant is approximately 1:3.5.In some embodiments, the ratio of oil to surfactant is approximately1:4. In some embodiments, the ratio of oil to surfactant isapproximately 1:4.5. In some embodiments, the ratio of oil to surfactantis approximately 1:5.

In some embodiments, the aqueous dispersion medium (e.g., water, buffer,salt solution, etc.) and surfactant are utilized at a ratio rangingbetween 0.01 and 20. In some embodiments, the aqueous dispersion medium(e.g., water, buffer, salt solution, etc.) and surfactant are utilizedat a ratio ranging between 0.1 and 20. In some embodiments, the aqueousdispersion medium (e.g., water, buffer, salt solution, etc.) andsurfactant are utilized at a ratio ranging between 0.5 and 10. In someembodiments, the aqueous dispersion medium (e.g., water, buffer, saltsolution, etc.) and surfactant are utilized at a ratio ranging between0.5 and 1. In some embodiments, the ratio of aqueous dispersion medium(e.g., water, buffer, salt solution, etc.) to surfactant isapproximately 0.01:1, approximately 0.02:1, approximately 0.03:1,approximately 0.04:1, approximately 0.05:1, approximately 0.06:1,approximately 0.07:1, approximately 0.08:1, approximately 0.0:1,approximately 0.1:1, approximately 0.2:1, approximately 0.3:1,approximately 0.4:1, approximately 0.5:1, approximately 1:1,approximately 2:1, approximately 3:1, approximately 4:1, approximately5:1, approximately 6:1, approximately 7:1, approximately 8:1,approximately 9:1 or approximately 10:1. In some embodiments, the ratioof surfactant to water is approximately 0.5:1, approximately 1:1,approximately 2:1, approximately 3:1, approximately 4:1, approximately5:1, approximately 6:1, approximately 7:1, approximately 8:1,approximately 9:1, approximately 10:1, approximately 11:1, approximately12:1, approximately 13:1, approximately 14:1, approximately 15:1,approximately 16:1, approximately 17:1, approximately 18:1,approximately 19:1, or approximately 20:1. In some embodiments, aqueousdispersion medium (e.g., water, buffer, salt solution, etc.) andsurfactant are utilized at a ratio ranging between 0.5 and 2. In someembodiments, the ratio of aqueous dispersion medium (e.g., water,buffer, salt solution, etc.) to surfactant is approximately 0.5:1,approximately 1:1, or approximately 2:1. In some embodiments, the ratioof surfactant to aqueous dispersion medium (e.g., water, buffer, saltsolution, etc.) is approximately 0.5:1, approximately 1:1, orapproximately 2:1. In some embodiments, the ratio of aqueous dispersionmedium (e.g., water, buffer, salt solution, etc.) to surfactant isapproximately 1:1. In some embodiments, compositions utilizing suchratios of aqueous dispersion medium (e.g., water, buffer, salt solution,etc.) to surfactant comprise water-in-oil emulsions.

The present invention also provides for particular cream and/or lotioncompositions that are particularly effective and/or useful in medicalcontexts, e.g., for therapeutic purposes. The present inventionencompasses the recognition that certain cream and/or lotionformulations are particularly useful and/or effective for topicaladministration of agents to a subject in need thereof. In someembodiments, the present invention provides certain cream and/or lotionformulations.

In some embodiments, known therapeutic agents and/or independentlyactive biologically active agents are admixed with a cream and/or lotionformulation for preparation of a topical pharmaceutical composition.

In some embodiments, a cream and/or lotion formulation comprisespurified water. In some embodiments, a cream and/or lotion formulationcomprises methylparaben. In some embodiments, a cream and/or lotionformulation comprises mineral oil. In some embodiments, a cream and/orlotion formulation comprises isopropyl myristate. In some embodiments, acream and/or lotion formulation comprises white petrolatum. In someembodiments, a cream and/or lotion formulation comprises emulsifyingwax. In some embodiments, a cream and/or lotion formulation comprisespropylparaben. In some embodiments, a cream and/or lotion formulationcomprises pemulen. In some embodiments, a cream and/or lotionformulation does not comprise pemulen.

In some embodiments, a cream and/or lotion formulation comprisespurified water, methylparaben, mineral oil, isopropyl myristate, whitepetrolatum, emulsifying wax, and propylparaben. In some embodiments, acream and/or lotion formulation consists essentially of purified water,methylparaben, mineral oil, isopropyl myristate, white petrolatum,emulsifying wax, and propylparaben. In some embodiments, a cream and/orlotion formulation consists of purified water, methylparaben, mineraloil, isopropyl myristate, white petrolatum, emulsifying wax, andpropylparaben.

In some embodiments, white petrolatum is or comprises a petrolatum agentselected from the group consisting of white petrolatum, wool wax,lanolin, Vasoliment, VASELINE® brand petroleum jelly, Saxoline,petroleum jelly, mineral jelly, mineral fat, mineral wax, paraffinjelly, yellow petrolatum, 2,6,10,15,19,23-hexamethyltetracosane,dodecahydrosqualene, perhydrosqualene, squalane, white VASELINE®, WhiteProtopet, Ultima White, Snow White, a substance corresponding to CASnumber 8009-03-8, and/or combinations thereof.

In some embodiments, a mineral oil is or comprises a mineral oil agentselected from the group consisting of paraffinic oils (e.g., oils basedon n-alkanes), naphthenic oils (e.g., oils based on cycloalkanes),aromatic oils (e.g., oils based on aromatic hydrocarbons), and/orcombinations thereof.

In some embodiments, an emulsifying wax is or comprises emulsifying waxNF (e.g., Spectrum Chemical catalog number W1026).

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation, many equivalents to the specificembodiments of the invention described herein.

The scope of the present invention is not intended to be limited to theabove Description, but rather is as set forth in the following claims:

We claim:
 1. A method for making an anti-sweating compositioncomprising; (viii) adding purified and/or deionized and/or distilledwater to a vessel with the necessary amounts and concentrations of NaOHand/or HCl or citric or acetic acid or other base or acid to raise orlower the pH of said water to 8.5 (±0.1); (ix) adding hydroxypropylcellulose powder to said vessel and stir a resulting solution until saidpowder is fully hydrolyzed; (x) lower pH of said solution to 7.0 (±0.1)using a 1N HCl solution and begin rapid mixing; (xi) adding Polysorbate20 as an emulsifier for stabilizing oils during mixing (xii) addingaluminum sesquichlorohydrate during mixing, thereby lowering pH of saidsolution (xiii) adding silicone oil during mixing and ensuring viscosityof said solution does not exceed 200 centipoise; (xiv) adding isopropylmyristate during mixing; (viii) adding alkyl benzoate during mixing;(ix) adding eucalyptus oil during mixing; (x) adding glycerine duringmixing; (xi) adding talc and/or arrowroot during mixing; (xii) addinghydrophobic silica slowly during mixing to avoid funing of fumed silicainto the atmosphere; (xiii) raising mixing speed once full amount ofsaid hydrophobic silica is added to said solution; (xix) adding acombination of phenoxyethanol and ethylhexyl glycerine as apreservative; (xx) adding hydrophilic silica in the same manner as steps(xii) and (xiii); and; completing said composition by mixing until saidcomposition is a stable homogeneous cream-like consistency.
 2. Themethod of claim 1, wherein said method is using chlorphenesin andcaprylyl glycol in lieu of ethyl hexyl glycerine.
 3. The method of claim1, wherein said method is using an aluminum hydrate and/or an aluminumchlorohydrate.
 4. The method of claim 1, wherein said method is usingonly hydrophobic silica.
 5. The method of claim 1, wherein said methodis using only hydrophilic silica.
 6. The method of claim 4, wherein saidhydrophilic silica is Aerosil 300 ® and said hydrophobic silica isAerosil R812®.
 7. The method of claim 1, wherein said silicone oil ispolydimethyl siloxane (PDMS).
 8. The method of claim 1, wherein saidalcohol is 2-propanol.
 9. The method of claim 1, wherein said alkylbenzoate is C12-C15 alkyl benzoate.
 10. The method of claim 1, whereinsaid glycerine is vegetable derived glycerine.
 11. The method of claim1, wherein a resulting composition using said method consistsessentially of the following weight percent of each component; 37-39percent water, 11-12 percent 2-propanol, 14-15 percent aluminumsesquichlorohydrate, 12-13 percent hydroxypropyl methylcellulose, 4-5percent polysorbate 20, 0.5-1.0 percent isopropyl myristate, 0.5-2.0percent eucalyptus oil, 0.5-1.5 percent poly dimethyl siloxane, 1.0-2.0alkyl benzoate, 0.5-1.0 percent glycerine, 1.0-3.0 percent talc, 5.0-7.0percent hydrophilic silica, 4.0-6.0 percent hydrophobic silica, and0.5-1.0 percent of the combination of phenoxyethanol and ethylhexylglycerine.
 12. The method of claim 10, wherein ethylhexyl glycerine isreplaced with chlorphenesin and caprylyl glycol at between 0.5 and 1.0percent.
 13. The method of claim 1, wherein said composition resultingfrom said method is selected from the group consisting of: a lotion, acream, a spray, a moisturizer, a balm, a paste, and a saline solution.14. The method of claim 1, wherein said composition is being used onhands or feet as needed or required by a user.
 15. A method of usingsaid composition of claim 1 comprising; providing a subject andadministering said composition to the skin of said subject.